"70518-0553-0" National Drug Code (NDC)

Terbinafine Hydrochloride 1 TUBE in 1 CARTON (70518-0553-0) > 30 g in 1 TUBE
(REMEDYREPACK INC.)

NDC Code70518-0553-0
Package Description1 TUBE in 1 CARTON (70518-0553-0) > 30 g in 1 TUBE
Product NDC70518-0553
Product Type NameHUMAN OTC DRUG
Proprietary NameTerbinafine Hydrochloride
Non-Proprietary NameTerbinafine Hydrochloride
Dosage FormCREAM
UsageTOPICAL
Start Marketing Date20170525
Marketing Category NameANDA
Application NumberANDA077511
ManufacturerREMEDYREPACK INC.
Substance NameTERBINAFINE HYDROCHLORIDE
Strength1
Strength Unitg/100g
Pharmacy ClassesAllylamine Antifungal [EPC], Allylamine [CS]

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